FRANKFORT, Ky. (Legal Newsline) - Bausch & Lomb, the eye products manufacturer, was found not liable for an injury possibly caused by the off-label use of one of its products in Kentucky.
In a ruling issued Dec. 11, the Kentucky Court of Appeals agreed with a lower court that the plaintiff, Karin Stiens, provided no evidence that B&L knew, or should have known that its product, Besivance, a treatment for pink eye, could cause injury when used as an antibacterial after PRK, a surgery on the cornea to correct near sightedness.
In the case, Dr. Lance Ferguson of Lexington applied Besivance to Stien’s left eye after surgery in 2012. Stien’s vision never improved and two years later she underwent a corneal transplant, which was unsuccessful.
In 2018, the Fayette Circuit Court dismissed claims of strict liability and breach of warranty against B&L and others, but initially denied summary judgment for B&L on a negligence claim. The court cited several scientific articles published in 2010 warning against the injection of Besivance into the eye during refractive surgery.
The articles could suggest that B&L knew or should have known of the risks associated with using Besivance in PRK, and B&L promoted its use anyway -- it was determined that a company representative did promote the product for use in PRK.
But the court prohibited all testimony associated with the off-label promotion of the drug when B&L pointed out that Stiens did not pursue claims under the federal Food, Drug and Cosmetic Act (FDCA), and therefore, could not claim that B&L violated the FDCA by promoting off label use of Besivance. The court then granted B&L’s motion for summary judgment.
Later, the court denied Stien’s Motion to Vacate and Reconsider Summary Judgment for failure to present new evidence or arguments. She appealed the ruling.
Appeals judge Allison Jones, writing for the majority, noted: “Each of Stiens’s claims under the Kentucky Product Liability Act – negligent marketing, failure to warn, and failure to test – is founded in negligence and requires evidence of foreseeability.”
She stated later in the opinion that “without a strict liability claim, Stiens cannot rely upon any presumption that B & L knew that off-label use of Besivance could cause injury.
“Given that Kentucky does not prohibit the off-label promotion and marketing of drugs, we do not believe that it is appropriate to extend the law of negligence in this regard. This is an issue for the General Assembly to take up, not the courts.”